Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)

Study acronym: ADVICE Phase 2
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 40 participants (planned 60)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 32 of 61 entries
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Feb 28, 2026 to Jul 28, 2026v4
  3. Study completion date: Jul 30, 2025 to Feb 28, 2026v3
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  5. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.
Trial Details
NCT Number NCT06884579
Lead Sponsor Universidad de Almeria
Collaborators: Hospital Universitario Virgen de la Arrixaca
Conditions
(from sponsor)		 Multiple Sclerosis (MS) - Relapsing-remitting
Related terms Fatigue, Feeding Behavior, Motor Activity, Multiple Sclerosis, Relapsing-Remitting
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov